Public Health England has withdrawn its guidance on Covid-19 testing that explicitly advised against providing such services within a community pharmacy.
New guidance on point-of-care (PoC) tests for the diagnosis of Covid-19 was issued by PHE on February 1. It sets out new requirements that apply to everyone providing a testing service, but it is unclear how this will apply to outlets such as pharmacies that might want to sell PoC test kits.
The new guidance says: “The 2020 Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations require all private coronavirus test providers to be engaged with the UK Accreditation Service (UKAS), and to have achieved UKAS accreditation for coronavirus testing, no later than June 2021. Also, coronavirus testing is now exempted as a regulated activity under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.”
The National Pharmacy Association says it is “seeking further clarity on PHE’s new position so that the full implications can be properly understood. We hope to be in a position to issue advice to members in the next few days. We are also contacting GPhC about revising its position, which is based on PHE’s now-defunct advice and currently excludes community pharmacies from providing this form of testing.”
The NPA says it has no plans to offer an in-pharmacy testing service for members at present, but a further announcement on testing can be expected next week.
“Previous PHE guidance had explicitly advised against point-of-care covid testing in pharmacies. We are pleased that following meetings between the NPA and PHE this earlier guidance has now been withdrawn,” the NPA added.
Lateral flow device antigen (LFD Ag) tests, which use a colour change on a test strip (similar to a pregnancy test) to directly detect non-nucleic acid antigens of coronavirus, are now in widespread use.
By November last year, four LFD Ag tests had been shown to detect coronavirus in over 70 per cent of infections and, critically, these tests detected almost all cases (over 95 per cent) with high viral loads.
LFD antibody tests have also been developed. These indicate whether a person has had a Covid infection in the past, but they cannot diagnose a current infection. An evaluation process to determine the accuracy of such tests is being set up.